Two new continuous glucose monitoring systems coming to market

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Two new over-the-counter continuous glucose monitoring systems have received approval for use in the United States.

Abbott received the nod from the U.S. Food and Drug Administration for the biowearable devices. Lingo is meant “for general consumers who are looking to improve their overall health and wellness,” while the Libre Rio monitor will be used by adults with Type 2 diabetes who do not use insulin but who manage diabetes with lifestyle modifications.

The Abbott Park, Illinois-based company this week announced the devices, which are based on its FreeStyle Libre CGM technology, which now is used by about 6 million people around the world. “The newly cleared systems have been intentionally designed to meet different needs,” the company’s news release said.

"There is no one-size-fits all approach for glucose monitoring, which is why we've designed different products for different people – all based on the same world-leading biowearable technology," Lisa Earnhardt, Abbott executive vice president and medical devices business group president, said in the news release. "People living with diabetes need certain features like tracking medications or sharing data with a healthcare provider. People without diabetes need different features to manage their metabolic health, including personalized coaching to promote actionable lifestyle changes."

Both devices are meant for users aged 18 years and older.

Better metabolic health

Abbott cited a University of North Carolina study that found only 12% of Americans are metabolically healthy based on five key indicators, including blood glucose levels. That indicates “most of the U.S. population has room to improve their metabolism.” Meanwhile, a survey by The Harris Poll, commissioned by Abbott, found 82% of Americans said they would change their habits if a biowearable device provided data to help them manage their health.

The Lingo device will have a biosensor worn on the upper arm for two weeks to continuously stream glucose data to a coaching application on a smart phone. That will offer insights about a person’s reaction to food, exercise, and life’s daily stressors, according to the company.

T2D

For patients managing Type 2 diabetes, Libre Rio will have a measurement range of 40 to 400 mg/dL, which can track extremely low or high glucose events. An estimated 38.4 million people live with diabetes, making it a top health challenged in the United States, Abbott said. The company noted its FreeStyle Libre systems are available for over-the-counter use in more than 50 countries, but it has been a prescription device in the United States.

Libre Rio will join the FreeStyle Libre 2 and FreeStyle Libre 3 systems serving patients with Type 1, Type 2 and gestational diabetes, according to Abbott.